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Androgen Biosynthesis Inhibitor

Abiraterone + Prednisone/Olaparib for Prostate Cancer

Phase 2

Waitlist Available

Led By Maha Hussain, MD, FACP, FASCO

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG status of 0-2 (Appendix A: Performance Status Criteria)

Serum testosterone < 50 ng/dL. Patients must continue primary ADT with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.

Must not have

Patients must stop taking all strong CYP3A4 inhibitors, including clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, and tipranavir, prior to registration.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib or abiraterone.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Summary

This trial is testing a new cancer treatment for men with metastatic castration resistant prostate cancer. It is a 1:1:1 randomized open-label multicenter phase II study, which means that patients will be randomly assigned to one of three different treatment groups. The study will take place at multiple centers, and patients will be observed over the course of the trial.

Who is the study for?

Men with metastatic castration-resistant prostate cancer and specific DNA repair defects (like ATM, BRCA mutations) can join. They must have a life expectancy of at least 6 months, be able to take oral meds, agree to use contraception for 3+ months after the trial, and not have had certain treatments like CYP17 inhibitors or chemotherapy for resistant disease. No major surgery or uncontrolled medical issues within 14 days before joining.Check my eligibility

What is being tested?

The study is testing three approaches: Abiraterone/Prednisone alone, Olaparib alone, or both combined in men with advanced prostate cancer who have genetic changes affecting DNA repair. It's an open-label phase II trial where patients are randomly assigned to one of the treatment arms.See study design

What are the potential side effects?

Possible side effects include fatigue, nausea, vomiting, low blood counts that could increase infection risk; liver problems; shortness of breath; rash; joint pain; high blood pressure and other heart-related issues. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of the day.

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My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had orchiectomy.

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I stopped taking hormone therapy for cancer 4 weeks ago and my PSA levels haven't dropped.

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I have been diagnosed with prostate adenocarcinoma, not small-cell carcinoma.

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I can swallow pills without needing to break them down.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have stopped taking all strong medications that affect liver enzymes.

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I am allergic to medications similar to olaparib or abiraterone.

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I am HIV-positive and on antiretroviral therapy, which may interact with the treatment.

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I have a specific DNA repair defect and severe disease in my organs or bones needing quick treatment.

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I haven't taken itraconazole, ketoconazole, or fluconazole in the last 3 weeks.

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I do not have a history of pituitary or adrenal problems, nor do I have active hepatitis or chronic liver disease.

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I have long-term blood-related issues, including bone marrow problems.

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I have moderate to severe liver problems.

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I have not had major surgery in the last 2 weeks or have fully recovered from it.

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I have a serious health condition that is not under control.

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I have not had a blood transfusion in the last 30 days.

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I do not have active Hepatitis B or C.

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I haven't taken any forbidden medications in the last week.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I have another active cancer besides non-dangerous skin cancer or superficial bladder cancer.

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I am not planning to undergo chemotherapy, surgery, or radiation while on the trial treatment.

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I have had a bone marrow transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Progression Free Survival (PFS)

Secondary outcome measures

Incidence of Adverse Events

Measurable disease response rate by RECIST

PSA response rate

+6 more

Trial Design

4Treatment groups

Active Control

Group I: Arm I: Abiraterone + PrednisoneActive Control2 Interventions

Abiraterone 1000 mg orally once daily and prednisone 5 mg orally twice daily, days 1-28 in 28 day cycles.

Group II: Arm II: OlaparibActive Control1 Intervention

Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.

Group III: Arm III: Abiraterone + Prednisone + OlaparibActive Control3 Interventions

Abiraterone 1000 mg orally once daily, prednisone 5 mg orally twice daily, olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.

Group IV: OlaparibActive Control1 Intervention

Olaparib 300 mg orally twice daily for days 1-28 in 28 day cycles.

0 / 22Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,608 Previous Clinical Trials

927,247 Total Patients Enrolled

20 Trials studying Prostate Cancer

2,959 Patients Enrolled for Prostate Cancer

AstraZenecaIndustry Sponsor

4,302 Previous Clinical Trials

288,624,529 Total Patients Enrolled

60 Trials studying Prostate Cancer

27,522 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,748 Previous Clinical Trials

40,959,331 Total Patients Enrolled

566 Trials studying Prostate Cancer

529,005 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Androgen Biosynthesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03012321 — Phase 2

Prostate Cancer Research Study Groups: Arm I: Abiraterone + Prednisone, Arm II: Olaparib, Arm III: Abiraterone + Prednisone + Olaparib, Olaparib

Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT03012321 — Phase 2

Abiraterone Acetate (Androgen Biosynthesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03012321 — Phase 2

~16 spots leftby Dec 2026

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